Omics in Valvular Disease: Biomarkers of Cardiac Remodeling, Left Ventricular Function, Intensive Care Unit Outcome, and Doppler Echocardiography (OVERLOAD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Description of the two serum biomarkers of mitochondrial dysfunction
研究概览
简要总结
The aim of our study is to investigate the effects of impaired left ventricular remodeling on the short- and long-term prognosis in AS partecipants undergoing extracorporeal circulation during valve repair surgery and in partecipants undergoing implantation transcatheter. For the achievement of these purposes, markers obtained from will be considered cardiovascular imaging methods, such as color Doppler echocardiography and isolated biomarkers from peripheral blood and heart tissue.
详细描述
Participation in this study includes, following enrollment, a visit of follow up (6/12 months) on the occasion of a concomitant medical check-up scheduled according to normal clinical practice. During these visits venous and contextual blood samples will be taken echocardiographic examination for re-evaluation of ejection fraction, as per normal practice clinic. The only variant will be the withdrawal of an additional aliquot of blood during the sampling standard blood.
All enrolled partecipants will undergo the optimal medical treatment provided by current and more recent guidelines for the treatment of heart valve disease. Joining this study will not result any modification of the current therapy, which will be established by the attending physician according to the correct one clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 patients with a diagnosis of severe aortic stenosis and preserved ejection fraction to echocardiographic evaluation
排除标准
- •inflammatory;
- •infectious diseases;
- •neoplasms;
- •ailments immunological or haematological;
- •treatment with anti-inflammatory drugs except aspirin a low dose (75-160 mg);
- •age > 85 years;
- •advanced chronic kidney disease with filtrate glomerular heart rate (eGFR) estimated by MDRD equation <30 ml/min./1.73 m2.
结局指标
主要结局
Description of the two serum biomarkers of mitochondrial dysfunction
时间窗: 1 year
Description of the two serum biomarkers of mitochondrial dysfunction Myeloperoxidase (MPO) and Lactoferrin (LF) and the indices of myocardial performance, systolic and diastolic function of the left ventricle in patients undergoing invasive (SAVR) or non-invasive (TAVR) monitoring.
次要结局
- Evaluation of the correlation between the two serum biomarkers of mitochondrial dysfunction(6 months)
- Evaluation of gene expression of molecular pathways involved in ventricular remodeling and correlation with echocardiographic parameters of left ventricular performance.(6 months)
研究者
Liuzzo Giovanna
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS